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High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study.

ABSTRACT: Etiology-specific onabotulinumtoxinA utilization to manage spasticity is largely unknown. In this 1-year interim analysis, we evaluated real-world onabotulinumtoxinA utilization and effectiveness across several etiologies from the Adult Spasticity International Registry (ASPIRE) study. ASPIRE is a multicenter, prospective, observational registry (NCT01930786) examining stroke, multiple sclerosis [MS], cerebral palsy [CP], traumatic brain injury [TBI], and spinal cord injury [SCI] patients with spasticity treated with onabotulinumtoxinA at the clinician's discretion. Assessments included onabotulinumtoxinA utilization (each session), clinician (subsequent session)/patient (5±1 weeks post-treatment) satisfaction, and the Disability Assessment Scale (DAS; subsequent session). 730 patients received ?1 onabotulinumtoxinA treatment, with 37% naïve to botulinum toxin(s) for spasticity. The most common etiology was stroke (n=411, 56%), followed by MS (N=119, 16%), CP (N=77, 11%), TBI (N=45, 6%), and SCI (N=42, 6%). The total body mean cumulative dose (±SD) of onabotulinumtoxinA per session ranged from 296 U (±145) in CP to 406 U (±152) in TBI. The most commonly treated upper limb presentations were clenched fist (stroke, MS, and SCI), flexed wrist (CP), and flexed elbow (TBI). Equinovarus foot was the most commonly treated lower limb presentation in all etiologies. Stroke patients showed improved DAS scores for nearly all subscales in both limbs, indicative of improved global function. All etiologies showed improved lower limb mobility DAS scores. Across all sessions, clinicians (range: 87.4% [SCI]-94.2% [CP]) and patients (range: 67.6% [TBI]-89.7% [SCI]) reported extreme satisfaction/satisfaction that onabotulinumtoxinA helped manage spasticity, and clinicians (range: 94.6% [TBI]-98.8% [CP]) and patients (range: 88.4% [stroke]-91.2% [TBI]) would definitely/probably continue treatment. Treatment-related adverse events (TRAEs) and treatment-related serious adverse events (TRSAEs) were reported as follows: stroke: 10 TRAEs (2.2% patients), 3 TRSAEs (0.5%); MS: 5 TRAEs (4.2%), 0 TRSAEs; CP: 0 TRAEs, 0 TRSAEs; TBI: 1 TRAEs (2.2%), 0 TRSAEs; SCI: 0 TRAEs, 0 TRSAEs. No new safety signals were identified. High clinician- and patient-reported satisfaction were observed following individualized onabotulinumtoxinA treatment, as well as improved global function. Interim results from ASPIRE demonstrate etiology-specific similarities and differences in clinical approaches to manage spasticity.

SUBMITTER: Francisco GE

PROVIDER: S-EPMC7452133 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study.

Francisco Gerard E GE Bandari Daniel S DS Bavikatte Ganesh G Jost Wolfgang H WH McCusker Emily E Largent Joan J Zuzek Aleksej A Esquenazi Alberto A

Toxicon: X 20200606

Etiology-specific onabotulinumtoxinA utilization to manage spasticity is largely unknown. In this 1-year interim analysis, we evaluated real-world onabotulinumtoxinA utilization and effectiveness across several etiologies from the Adult Spasticity International Registry (ASPIRE) study. ASPIRE is a multicenter, prospective, observational registry (NCT01930786) examining stroke, multiple sclerosis [MS], cerebral palsy [CP], traumatic brain injury [TBI], and spinal cord injury [SCI] patients with s ...[more]

PMID: 32875289

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Project description:IntroductionOnabotulinumtoxinA treatment for spasticity is dependent on numerous factors and varies according to selected treatment goals.ObjectiveTo examine real-world onabotulinumtoxinA treatment utilization and effectiveness in patients with upper limb spasticity over 2 years from the Adult Spasticity International Registry (ASPIRE) study.DesignMulticenter, prospective, observational registry (NCT01930786).SettingFifty-four international clinical sites in North America, Europe, and Asia.PatientsAdults (naïve or non-naïve to botulinum toxins for spasticity) with upper limb focal spasticity related to upper motor neuron syndrome across multiple etiologies.InterventionsOnabotulinumtoxinA administered at clinician's discretion.Main outcome measuresOnabotulinumtoxinA utilization, clinician and patient satisfaction.ResultsFour hundred eighty-four patients received ≥1 treatment of onabotulinumtoxinA for upper limb spasticity. Patients were on average 55.1 years old, 50.8% male, predominantly Caucasian (72.3%), and 38.6% were naïve to botulinum toxins. Stroke was the most frequently reported underlying etiology (74.0%). Most patients (81.2%) had moderate to severe spasticity at baseline. The most commonly treated upper limb clinical presentation was clenched fist (79.1% of patients). Across all presentations, onabotulinumtoxinA doses ranged between 5-600U. Electromyography (EMG) was most often utilized to localize muscles (≥57.0% of treatment sessions). Clinicians (92.9% of treatment sessions) and patients (85.7%) reported being extremely satisfied/satisfied that treatment helped manage spasticity, and clinicians (98.6%) and patients (92.2%) would definitely/probably continue onabotulinumtoxinA treatment. One hundred seventy-nine patients (37.0%) reported 563 adverse events (AEs); 15 AEs in 14 patients (2.9%) were considered treatment related. Sixty-nine patients (14.3%) reported 137 serious AEs; 3 serious AEs in 2 patients (0.4%) were considered treatment related. No new safety signals were identified.ConclusionsASPIRE captured the real-world individualized nature of onabotulinumtoxinA utilization for upper limb spasticity over 2 years, with consistently high clinician- and patient-reported satisfaction. Data in this primary analysis will guide clinical use of onabotulinumtoxinA, as well as provide insights to improve educational programs on spasticity management.

Project description:Importance:Prior studies suggesting clinician fulfillment or denial of requests affects patient satisfaction included limited adjustment for patient confounders. The studies also did not examine distinct request types, yet patient expectations and clinician fulfillment or denial might vary among request types. Objective:To examine how patient satisfaction with the clinician is associated with clinician denial of distinct types of patient requests, adjusting for patient characteristics. Design, Setting, and Participants:Cross-sectional observational study of 1319 outpatient visits to family physicians (n = 56) by 1141 adults at one Northern California academic health center. Main Outcomes and Measures:We used 6 Consumer Assessment of Healthcare Providers and Systems Clinician and Group Adult Visit Survey items to measure patient satisfaction with the visit physician. Standardized items were averaged to form the satisfaction score (Cronbach α = 0.80), which was then percentile-transformed. Seven separate linear mixed-effects models examined the adjusted mean differences in patient satisfaction percentile associated with denial of each of the following requests (if present)-referral, pain medication, antibiotic, other new medication, laboratory test, radiology test, or other test-compared with fulfillment of the respective requests. The models adjusted for patient sociodemographics, weight, health status, personality, worry over health, prior visit with clinician, and the other 6 request categories and their dispositions. Results:The mean (SD) age of the 1141 patients was 45.6 (16.1) years, and 902 (68.4%) were female. Among 1319 visits, 897 (68.0%) included at least 1 request; 1441 (85.2%) were fulfilled. Requests by category were referral, 294 (21.1%); pain medication, 271 (20.5%); antibiotic, 107 (8.1%); other new medication, 271 (20.5%); laboratory test, 448 (34.0%); radiology test, 153 (11.6%); and other tests, 147 (11.1%). Compared with fulfillment of the respective request type, clinician denials of requests for referral, pain medication, other new medication, and laboratory test were associated with worse satisfaction (adjusted mean percentile differences, -19.75 [95% CI, -30.75 to -8.74], -10.72 [95% CI, -19.66 to -1.78], -20.36 [95% CI, -29.54 to -11.18], and -9.19 [95% CI, -17.50 to -0.87]), respectively. Conclusions and Relevance:Clinician denial of some types of requests was associated with worse patient satisfaction with the clinician, but not for others, when compared with fulfillment of the requests. In an era of patient satisfaction-driven compensation, the findings suggest the need to train clinicians to deal effectively with requests, potentially enhancing patient and clinician experiences.

Dataset Information

High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study.

Publications

High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study.

Similar Datasets

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